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Surgery Followed by Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Study Purpose

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. External-beam radiation therapy uses high-energy x-rays to kill tumor cells. Combining internal radiation with external-beam radiation therapy may kill any remaining tumor cells following surgery. PURPOSE: Phase I trial to study the effectiveness of combining internal radiation therapy with external-beam radiation therapy in treating patients who have undergone surgery for glioblastoma multiforme.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Clinically suspected supratentorial grade IV glioblastoma multiforme.
  • - Candidate for maximal surgical resection of tumor mass.
  • - Expected residual enhancing tumor must be within the expected brachytherapy treatment volume.
  • - Resection must not be expected to result in a new permanent neurologic deficit.
  • - No clearly multi-focal disease (2 or more separate foci of contrast-enhancing tumor not all within the expected brachytherapy prescription volume by MRI) - No enhancing tumor greater than 1 cm beyond the midline by MRI.
  • - No grossly or radiographically apparent leptomeningeal spread and/or ventricular invasion outside the anticipated radiation treatment volume.
  • - No marked edema by MRI with significant shift that is not anticipated to be corrected by resection.
PATIENT CHARACTERISTICS: Age.
  • - 18 and over.
Performance status.
  • - Karnofsky 60-100% Life expectancy.
  • - Not specified.
Hematopoietic.
  • - Absolute neutrophil count at least 1,500/mm^3.
  • - Platelet count at least 100,000/mm^3.
Hepatic.
  • - Not specified.
Renal.
  • - Creatinine no greater than 1.7 mg/dL.
  • - BUN no greater than 2 times upper limit of normal.
Cardiovascular.
  • - No uncontrolled hypertension.
  • - No unstable angina pectoris.
  • - No uncontrolled cardiac dysrhythmia.
Other.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
  • - Mini mental state exam score at least 15.
  • - No other concurrent medical illness that would preclude study participation.
  • - No concurrent serious infection.
  • - No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer.
PRIOR CONCURRENT THERAPY: Biologic therapy.
  • - No immunotherapy prior to, during, or within 90 days after brachytherapy.
  • - No biologic therapy with any of the following prior to, during, or within 90 days after brachytherapy : - Immunotoxins.
  • - Immunoconjugates.
  • - Antiangiogenesis compounds.
  • - Peptide receptor antagonists.
  • - Interferons.
  • - Interleukins.
  • - Tumor-infiltrating lymphocytes.
  • - Lymphokine-activated killer cells.
  • - Gene therapy.
  • - Antisense agents.
Chemotherapy.
  • - No chemotherapy or polifeprosan 20 with carmustine implant (Gliadel wafers) prior to, during, or within 90 days after brachytherapy.
Endocrine therapy.
  • - No hormonal therapy prior to, during, or within 90 days after brachytherapy.
  • - Concurrent corticosteroids to improve quality of life allowed.
Radiotherapy.
  • - No other radiotherapy prior to, during, or within 90 days after brachytherapy.
Surgery.
  • - See Disease Characteristics.
  • - No radiosurgery prior to, during, or within 90 days after brachytherapy.
Other.
  • - No other investigational agents directed at the brain tumor prior to, during, or within 90 days after brachytherapy.
- Concurrent noncytotoxic therapy to improve quality of life allowed

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00053183
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Volker W. Stieber, MD
Principal Investigator Affiliation Wake Forest University Health Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - Determine the maximum tolerated dose of brachytherapy administered via GliaSite RTS™ applicator followed by external beam radiotherapy in patients with newly diagnosed glioblastoma multiforme.
  • - Determine the acute and chronic toxicity of brachytherapy administered via GliaSite RTS™ in these patients.
  • - Determine the survival rate of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of brachytherapy. Patients undergo craniotomy for histologic confirmation of glioblastoma multiforme, surgical resection, and placement of a GliaSite RTS™ applicator that includes Iotrex™. Beginning 3-21 days after surgery, patients undergo brachytherapy via the GliaSite RTS™ applicator. Within 30 days of brachytherapy (no more than 60 days after resection) patients undergo external beam radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 5 or 3 of 10 patients experience dose-limiting toxicity. Patients are followed at 21-35 days, every 2 months for 1 year, and then for survival. PROJECTED ACCRUAL: A total of 15-100 patients will be accrued for this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Birmingham, Alabama

Status

Address

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3295

Tampa, Florida

Status

Address

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497

Atlanta, Georgia

Status

Address

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

Baltimore, Maryland

Status

Address

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231

Boston, Massachusetts

Status

Address

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

Detroit, Michigan

Status

Address

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202

Winston-Salem, North Carolina

Status

Address

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio

Status

Address

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195

Philadelphia, Pennsylvania

Status

Address

Abramson Cancer Center at University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104

San Antonio, Texas

Status

Address

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811

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